Class 2 Device Recall SureForm Stapler

• Date Initiated by Firm: March 17, 2022
• Create Date: April 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0999-2022
• Recall Event ID: 89736
• 510(K)Number: K183224 K190999 K173721
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinici X da Vinci Xi Sureform 45 REF 480445; ; da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545; ; da Vinici X da Vinci Xi Sureform 60 REF 480460
• Code Information: Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: Customer Service; 800-876-1310 Ext. 3
• Manufacturer Reason for Recall: As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.
• FDA Determined Cause: Under Investigation by firm
• Action: On 03/17/2022, the firm sent an "Urgent Medical Device Correction" letter via FedEx informing customers that there is a potential for injury associated with the stapler instruments if target tissue fails to remain in place with the jaws of the stapler during the stapler firing sequence. This phenomenon is referred to as a "tissue pushout event". As the staple firing sequence progresses, the target tissue is transected but the target tissue is not approximated due the lack of staple engagement with the tissue. This type of event may result in un-approximated tissue and occurs when attempting to cross over existing staple lines in the creation of a continuous staple line. Customer are being instructed to place the customer communication with the User Manual and in addition: 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the Surgical System that they should review and understand contents of this letter and reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the SureForm Instruments and Accessories User Manual Addendum b. Contacting their Sales Representatives for clarification of queries. 3. Complete the Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for their files. Customers are also informed that they can continue to use their instruments by following instructions: -Users are advised to use caution when unable to avoid crossing over existing staple lines and continue to adhere to all existing warnings and cautions found in the SureForm Instruments and Accessories User Manual Addendum. -If a tissue pushout event is occurring, users may limit unapproximated tissue by pressing the emergency stop button (on Surgeon Console or Patient Cart helm), after which the SureForm stapler can be safely unclamped from the tissue using the Manual Release Knob. For questions or fu
• Quantity in Commerce: 6,8881 boxes (or 413,286 individual units/6 instruments/box)
• Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical; 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc.